Intermittent Positive-Pressure VentilationNCT06537388
High Frequency Jet Ventilation Versus Conventional Positive Pressure Ventilation for EBUS
An observational study of Intermittent Positive-Pressure Ventilation and High-Frequency Jet Ventilation, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Endobronchial ultrasound (EBUS) is frequently used in pneumology for diagnostic procedures like mediastinal biopsies. This procedure is usually done under general anesthesia. Different methods of ventilation are used according to center and physician preferences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Positive-Pressure Ventilation, High-Frequency Jet Ventilation, Ultrasonography, Interventional
- What is being tested?
- Ventilation type
- Type of treatment
- Surgery or procedure
- How many people
- 428 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Aug 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent EBUS for any indication at Erasme University Hospital using either HFJV or IPPV between january 1st 2019 and december 31st 2019 or january 1st 2023 and december 31st 2023.
Who may be able to join
- All patients who underwent EBUS at Erasme University Hospital using either HFJV or IPPV between january 1st 2019 and december 31st 2019 or january 1st 2023 and december 31st 2023.
Who cannot join
- Incomplete medical chart
- Patients who expressed an opposition to the use of their medical data
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Hôpital Universitaire de Bruxelles - Hôpital erasme
Brussels, 1070
About this study
Official title: Comparison of High Frequency Jet Ventilation and Conventional Positive Pressure Ventilation for Endobronchial Ultrasound Examinations
Endobronchial ultrasound (EBUS) is frequently used in pneumology for diagnostic procedures like mediastinal biopsies. This procedure is usually done under general anesthesia. Different methods of ventilation are used according to center and physician preferences. In this retrospective study, complications of 2 types of ventilation will be analyzed:
- High frequency jet ventilation (HFJV)
- Conventional intermittent positive pressure ventilation (IPPV) Descriptive statistics will be used to present the data. Both ventilation techniques will be compared after propensity score matching. For HFJV patients from 2019 will be analyzed and for IPPV patients from 2023, as the team changed its practice over time.
- Conditions
- Intermittent Positive-Pressure Ventilation, High-Frequency Jet Ventilation, Ultrasonography, Interventional
- Being tested
- Ventilation type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilation typeProcedure or surgery
Type of ventilation used during the EBUS procedure, either HFJV or IPPV
| Study group | Role | What they receive |
|---|---|---|
| EBUS_cohort | All patients who underwent EBUS between January 1st 2019 and december 31st 2019 or January 1st 2023 and december 31st 2023 at Erasme University Hospital Receives: Procedure: Ventilation type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxia
defined as an SpO2 < 90% for more than 1 min
Measured: 24 hours
Severe hypoxia
defined as an SpO2 (oxygen saturation by pulse oximetry) < 85% for more than 1 min
Measured: 24 hours
Hemodynamic instability
defined as a systolic arterial blood pressure < 90/60 mm Hg
Measured: 24 hours
Cardiac arrythmia
Any cardiac rhythm other than sinus rhythm
Measured: 24 hours
Laryngospasm
Any occurence of laryngospasm
Measured: 24 hours
ICU admission
Necessity for admission to the intensive care unit (ICU)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start15 Aug 2024
- Primary completion30 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intermittent Positive-Pressure VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537388
- Sponsor's protocol ID
- SRB2024173
- Status last verified
- May 2025
- First submitted
- 1 Aug 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prasad KT, Sehgal IS, Gupta N, Singh N, Agarwal R, Dhooria S. Endoscopic ultrasound (with an echobronchoscope)-guided fine-needle aspiration for diagnosis of a mediastinal lesion in a mechanically ventilated patient: A case report and systematic review of the literature. Indian J Crit Care Med. 2016 Oct;20(10):608-612. doi: 10.4103/0972-5229.192057.
PubMed 27829719Anwar M, Fritze R, Base E, Wasserscheid T, Wolfram N, Koinig H, Hackner K, Lambers C, Schweiger T, Errhalt P, Hoda MA. Infraglottic versus supraglottic jet-ventilation for endobronchial ultrasound-guided transbronchial needle aspiration: A randomised controlled trial. Eur J Anaesthesiol. 2020 Nov;37(11):999-1007. doi: 10.1097/EJA.0000000000001220.
PubMed 32453167Poling HE, Wolfson B, Siker ES. A technique of ventilation during laryngoscopy and bronchoscopy. Br J Anaesth. 1975 Mar;47(3):382-4. doi: 10.1093/bja/47.3.382.
PubMed 1138745Klain M, Smith RB. High frequency percutaneous transtracheal jet ventilation. Crit Care Med. 1977 Nov-Dec;5(6):280-7. doi: 10.1097/00003246-197711000-00007. No abstract available.
PubMed 338247Hautmann H, Gamarra F, Henke M, Diehm S, Huber RM. High frequency jet ventilation in interventional fiberoptic bronchoscopy. Anesth Analg. 2000 Jun;90(6):1436-40. doi: 10.1097/00000539-200006000-00034.
PubMed 10825336
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High Frequency Jet Ventilation and Conventional Positive Pressure Ventilation for Endobronchial Ultrasound Examinations
- ClinicalTrials.gov ID
- NCT06537388
- Acronym / sponsor ID
- SRB2024173
- Conditions
- Intermittent Positive-Pressure Ventilation, High-Frequency Jet Ventilation, Ultrasonography, Interventional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endobronchial ultrasound (EBUS) is frequently used in pneumology for diagnostic procedures like mediastinal biopsies. This procedure is usually done under general anesthesia. Different methods of ventilation are used according to center and physician preferences. In this retrospective study, complications of 2 types of ventilation will be analyzed:
- High frequency jet ventilation (HFJV)
- Conventional intermittent positive pressure ventilation (IPPV) Descriptive statistics will be used to present the data. Both ventilation techniques will be compared after propensity score matching. For HFJV patients from 2019 will be analyzed and for IPPV patients from 2023, as the team changed its practice over time.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBUS_cohort | – | Procedure: Ventilation typeAll patients who underwent EBUS between January 1st 2019 and december 31st 2019 or January 1st 2023 and december 31st 2023 at Erasme University Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent EBUS for any indication at Erasme University Hospital using either HFJV or IPPV between january 1st 2019 and december 31st 2019 or january 1st 2023 and december 31st 2023.
Key inclusion criteria (1 listed)
- All patients who underwent EBUS at Erasme University Hospital using either HFJV or IPPV between january 1st 2019 and december 31st 2019 or january 1st 2023 and december 31st 2023.
Key exclusion criteria (3 listed)
- Incomplete medical chart
- Patients who expressed an opposition to the use of their medical data
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilation typeType of ventilation used during the EBUS procedure, either HFJV or IPPV | Procedure or surgery | EBUS_cohort |
Primary outcome
Hypoxia
Time frame: 24 hours
defined as an SpO2 < 90% for more than 1 min
Severe hypoxia
Time frame: 24 hours
defined as an SpO2 (oxygen saturation by pulse oximetry) < 85% for more than 1 min
Hemodynamic instability
Time frame: 24 hours
defined as a systolic arterial blood pressure < 90/60 mm Hg
Cardiac arrythmia
Time frame: 24 hours
Any cardiac rhythm other than sinus rhythm
Laryngospasm
Time frame: 24 hours
Any occurence of laryngospasm
ICU admission
Time frame: 24 hours
Necessity for admission to the intensive care unit (ICU)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Background: PubMed 27829719Prasad KT, Sehgal IS, Gupta N, Singh N, Agarwal R, Dhooria S. Endoscopic ultrasound (with an echobronchoscope)-guided fine-needle aspiration for diagnosis of a mediastinal lesion in a mechanically ventilated patient: A case report and systematic review of the literature. Indian J Crit Care Med. 2016 Oct;20(10):608-612. doi: 10.4103/0972-5229.192057.
- Background: PubMed 32453167Anwar M, Fritze R, Base E, Wasserscheid T, Wolfram N, Koinig H, Hackner K, Lambers C, Schweiger T, Errhalt P, Hoda MA. Infraglottic versus supraglottic jet-ventilation for endobronchial ultrasound-guided transbronchial needle aspiration: A randomised controlled trial. Eur J Anaesthesiol. 2020 Nov;37(11):999-1007. doi: 10.1097/EJA.0000000000001220.
- Background: PubMed 1138745Poling HE, Wolfson B, Siker ES. A technique of ventilation during laryngoscopy and bronchoscopy. Br J Anaesth. 1975 Mar;47(3):382-4. doi: 10.1093/bja/47.3.382.
- Background: PubMed 338247Klain M, Smith RB. High frequency percutaneous transtracheal jet ventilation. Crit Care Med. 1977 Nov-Dec;5(6):280-7. doi: 10.1097/00003246-197711000-00007. No abstract available.
- Background: PubMed 10825336Hautmann H, Gamarra F, Henke M, Diehm S, Huber RM. High frequency jet ventilation in interventional fiberoptic bronchoscopy. Anesth Analg. 2000 Jun;90(6):1436-40. doi: 10.1097/00000539-200006000-00034.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intermittent Positive-Pressure Ventilation and High-Frequency Jet Ventilation, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxia (time frame: 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06537388, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.